24962 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

(Comment 4) One comment states that 

Medication Guides increasingly become 

accessible online for download and 

print and the costs for printing, 

including paper, toner, administrative, 

and software costs, have shifted from 

the manufacturers to the pharmacies. 

(Response) While Medication Guides 

are increasingly available online for 

download and printing, the FDA does 

not agree that a financial and 

acquisition burden has shifted to or 

been created for dispensers. The 

comment mischaracterizes the cost to 

dispensers associated with the 

distribution of Medication Guides. For 

purposes of information collection 

requests under the PRA, capital costs 

are costs for equipment, machinery, and 

construction that, if not for FDA’s 

request or requirement, the respondent 

would not incur. Capital costs do not 

include costs to achieve regulatory 

compliance. The costs presented by the 

comment are not capital costs because 

they are costs associated with achieving 

regulatory compliance with 

requirements of the FD&C Act, not costs 

associated specifically with equipment, 

machinery, and construction needed to 

retain appropriate substantiating 

evidence. 

(Comment 5) One comment states that 

the length of Medication Guides 

continues to be burdensome and 

hinders a pharmacist from utilizing a 

potentially effective tool. The comment 

stresses the need for a succinct, onepage document that can be easily 

integrated into current pharmacy 

practice workflow. 

(Response) FDA generally agrees with 

the comment and is currently in the 

process of evaluating whether a onepage solution can be implemented. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual responses Average burden per 

response Total hours 

208.20 .................................... 25 1 25 320 8,000 

314.70(b)(3)(ii), 601.12(f) ...... 5 1 5 72 360 

208.24(e) ............................... 59,000 5,000 295 million 3 minutes 14,750,000 

208.26(a) ............................... 1 1 1 4 4 

Total ............................... ........................ ........................ ............................................... ............................................... 14,758,364 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: April 20, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–10022 Filed 4–25–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 

(44 U.S.C. chapter 35). To request a 

copy of the clearance requests submitted 

to OMB for review, email 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1984. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Assessing Factors 

That Impact AIDS Drug Assistance 

Program (ADAP) Enrollment and 

Management in the Face of ADAP 

Waiting Lists (OMB No. 0915–xxxx)— 

[New] 

HRSA’s AIDS Drug Assistance 

Program (ADAP) provides assistance to 

help low-income, uninsured and 

underinsured individuals living with 

HIV/AIDS get access to life-saving 

medications. As part of the Ryan White 

HIV/AIDS Program, ADAP is the payer 

of last resort. Clients enrolled in ADAP 

have exhausted all other resources to 

obtain necessary medications and care. 

In recent years, ADAP has experienced 

an increase in enrollment while funding 

resources have decreased. 

This study will use case study 

methods to identify and examine factors 

that contribute to the rising enrollments 

in ADAP and States’ abilities to meet 

demands for ADAP services. Data 

collection will include interviews with 

up to eight respondents in each of eight 

selected states, for a maximum of 64 

total respondents. Each interview will 

last approximately one and a half hours. 

The respondents fall into three general 

categories—ADAP personnel, State HIV/ 

AIDS program leads, and personnel 

from related State and local programs 

such as Medicaid and pharmacy 

assistance programs. Interviews will be 

conducted over a period of two and a 

half months. 

The proposed study will assess factors 

that may contribute to the rise in ADAP 

enrollment and costs such as new HIV 

cases, earlier use of antiretroviral 

medications, lower attrition of existing 

clients, unemployment and loss of 

insurance, or increasing drug costs. In 

addition, the study will examine factors 

that may decrease ADAP costs such as 

health care reform and cost containment 

strategies. Findings from the study will 

be used to develop policy and to 

recommend promising practices for 

managing ADAPs. 

The annual estimate of burden is as 

follows: 

Activity Number of 

respondents 

Responses per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

ADAP Site Visit Coordination .......................... 8 1 8 1 8 

Instrument: 

ADAP Personnel Interview ....................... 32 1 32 1.5 48 

State HIV/AIDS Lead Interview ................ 8 1 8 1.5 12 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24963 

Activity Number of 

respondents 

Responses per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Alternative State/Local Program Informant 

Interview ................................................ 24 1 24 1.5 36 

Total ................................................... 72 ............................ ............................ ............................ 104 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by 

email to 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. Please direct all 

correspondence to the ‘‘attention of the 

desk officer for HRSA.’’ 

Dated: April 19, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–10032 Filed 4–25–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 

(44 U.S.C. chapter 35). To request a 

copy of the clearance requests submitted 

to OMB for review, email paperwork@

hrsa.gov or call the HRSA Reports 

Clearance Office on (301) 443–1984. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Uncompensated 

Services Assurance Report (OMB No. 

0915–0077)—[Revision] 

Under the Hill-Burton Act, the 

Government provides grants and loans 

for construction or renovation of health 

care facilities. As a condition of 

receiving this construction assistance, 

facilities are required to provide 

services to persons unable to pay. A 

condition of receiving this assistance 

requires facilities to provide assurances 

periodically that the required level of 

uncompensated care is being provided, 

and that certain notification and record 

keeping procedures are being followed. 

These standard requirements are 

referred to as the uncompensated 

services assurance. 

The annual estimate of burden is as 

follows: 

ESTIMATE OF INFORMATION COLLECTION BURDEN

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Disclosure Burden (42 CFR) 

Published Notices (124.504(c)) ........................................... 63 1 63 0.75 47.25 

Individual Notices (124.504(c)) ............................................ 63 1 63 43.60 2,746.80 

Determinations of Eligibility (124.507) ................................. 63 99 6,237 0.75 4,677.75 

Subtotal Disclosure Burden .......................................... ........................ ........................ ........................ ........................ 7,471.80 

Reporting 

Uncompensated Services Report—HRSA–710 Form 

(124.509(a)) ...................................................................... 10 1 10 11.00 110.00 

Application for Compliance Alternatives 

Public Facilities (124.513) .................................................... 4 1 4 6.00 24.00 

Small Obligation Facilities (124.514(c)) ............................... 0 ........................ ........................ ........................ ........................

Charitable Facilities (124.516(c)) ......................................... 0 ........................ ........................ ........................ ........................

Annual Certification for Compliance Alternatives 

Public Facilities (124.509(b)) ............................................... 32 1 32 0.50 16.00 

Charitable Facilities (124.509(b)) ......................................... 13 1 13 0.50 6.50 

Small Obligation Facilities (124.509(c)) ............................... 0 ........................ 0 ........................ ........................

Complaint Information (124.511(a)) 

Individuals ............................................................................ 10 1 10 0.25 2.50 

Facilities ............................................................................... 10 1 10 0.50 5.00 

Subtotal Reporting Burden ........................................... ........................ ........................ ........................ ........................ 164.00 


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